Jazz Pharmaceuticals Announces Positive Results from the Phase 3 TONES 2 Study of JZP-110 in Narcolepsy Patients with Excessive Sleepiness
"Excessive sleepiness in narcolepsy remains an important unmet medical need, and we believe that the statistically and clinically significant effect observed in this study indicates that JZP-110 could be an important treatment option for patients," said
"Patients with narcolepsy struggle with excessive sleepiness, which is the symptom of narcolepsy that patients report as having the most significant impact on their daily lives," said
The Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program is comprised of four studies, two in obstructive sleep apnea (OSA) (TONES 3 and TONES 4 studies), one in narcolepsy (TONES 2 study) and one open-label, long-term safety and maintenance of efficacy study. The TONES 2 study enrolled 240 patients. The company plans to present the results from the TONES 2, TONES 3 and TONES 4 studies assessing the effect of JZP-110 on excessive sleepiness in narcolepsy and OSA at the APSS meeting in June.
Efficacy and Preliminary Safety Results of TONES 2 Study
The TONES 2 study, or 14-002, is a 4-arm, parallel-group study evaluating three doses of JZP-110 (300 mg, 150 mg, and 75 mg) compared to placebo for a 12-week period.
In TONES 2, JZP-110 demonstrated highly statistically significant improvement in the co-primary endpoints of the Maintenance of Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS) and in the key secondary endpoint of the Patient Global Impression of Change (PGIc) scale at the 300 mg and 150 mg doses compared to placebo. These effects were maintained throughout the course of the study. The JZP-110 75 mg dose reached statistical significance on the co-primary endpoint of ESS, but did not reach statistical significance on the co-primary endpoint of MWT.* The endpoints of MWT and ESS measure patients' ability to stay awake and patients' subjective levels of sleepiness, respectively.
Based on a preliminary safety analysis, the most commonly reported adverse events across all doses in TONES 2 were headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety. There was one patient with two serious adverse events (SAEs) on JZP-110 that were considered not treatment related as assessed by the investigator. The open-label, long-term safety and maintenance of efficacy study is ongoing, and the results will be included in the planned New Drug Application (NDA) submission.
About the Global Phase 3 TONES 2 Study
TONES 2 is a 12-week, 4-arm, parallel-group, double-blind, placebo-controlled, randomized Phase 3 study evaluating the safety and efficacy of JZP-110 in adults with excessive sleepiness in narcolepsy. Patients were randomized 1:1:1:1 to JZP-110 300 mg, 150 mg, 75 mg and placebo. The co-primary endpoints are the change in mean sleep latency on the MWT and the change in the ESS score from baseline to week 12. The key secondary endpoint is the percentage of patients who report improvement on the PGIc scale, a patient-reported measure of improvement, worsening, or no change in overall condition from baseline to week 12. The TONES 2 study enrolled 240 patients.
For information about the TONES 3 and TONES 4 studies, refer to the company's press release dated
About Narcolepsy
Narcolepsy is a debilitating neurological disorder characterized by excessive sleepiness, and the inability to regulate sleep-wake cycles normally. It affects an estimated one in 2,000 people in
About JZP-110
JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in late-stage development for treatment of excessive sleepiness in adult patients with narcolepsy or OSA. In 2014,
Across the entire JZP-110 development program, over 2,000 subjects have enrolled in 20 studies. The JZP-110 Phase 3 clinical program includes two studies evaluating excessive sleepiness in adult patients with OSA (TONES 3 and TONES 4), one study evaluating excessive sleepiness in adult patients with narcolepsy (TONES 2) and an open-label, long-term safety and maintenance of efficacy study. Enrollment is complete in all studies that are expected to support the planned JZP-110 NDA submission to the
About
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to JZP-110 as a potential treatment for excessive sleepiness in adult patients with narcolepsy, the expected presentation of JZP-110 study results at APSS, the company's plans for submission of an NDA for JZP-110 with the
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SOURCE
Investors: Kathee Littrell, Vice President, Investor Relations, Ireland, +353 1 634 7887, U.S., +1 650 496 2717; or Media: Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations, Ireland, +353 1 697 2141, U.S., +1 215 867 4910
* This information was corrected on April 28, 2017. The original version stated that the 75mg dose reached statistical significance on the co-primary endpoint of MWT and did not reach statistical significance on the co-primary endpoint of ESS.